Eli Lilly and (LLY) 3 Aug 212021 Q2 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to Lilly’s Q2 Earnings Call. [Operator Instructions].

As a reminder, today's conference is being recorded. I would now like to turn the conference over to our host, Vice President of Investor Relations, Kevin Hern. Please go ahead.

morning. Good joining Lilly for XXXX Company's for call. earnings us you and Eli QX Thank Vice Investor President Hern, Kevin I'm of Relations. Chief And joining Chairman Officer; Ashkenazi, Lilly's Dave are Dr. Financial me on and today's CEO; call Ricks, Anat and Officer Ilya Oncology of at of Oncology; of Lilly Scientific Chief and President Skovronsky, Medical Anne Van of Yuffa, Mason, White, Mike Bio-Medicines; Loxo Jake Lilly. Officer; Lilly Diabetes; Lilly President President CEO Dan Naarden,

Zierke, We team. [indiscernible] joined are Lauren Sara Relations by the of Smith Investor also

projections making and statements During this anticipate conference we our on expectations. forward-looking current call, based

actual due Our on to number of results X. listed those a could differ materially factors, Slide including

Securities information contained Exchange we information cause about in is could actual the Commission. subsequent for our factors Forms provide to is It products not community. latest of the decisions. not materially sufficient and promotional, XX-K benefit differ X-K intended and Additional our be and concerning for investment is prescribing Forms the The results pipeline that is and XX-Q to with and filed

As to on commentary measures. our non-GAAP financial a will remarks, we reminder our focus transition that prepared

call to turn the of over quarter I'll Dave summary for our Now second a results.

Kevin. QX the negative one year ways, combat also colleagues Lilly help COVID-XX. to our in was of the against objectives pandemic’s innovation And proud mobilizing peak new to year while displayed our of business. of I'm treatments my by last impact later, to the you, resilience Thank and to develop deliver

in core growth today's in key including first XX% by comparisons. at and half Looking in rates, half business. underlying the our in our In XXXX major for year, growth environment Therefore, we XXXX, major last growth call, related reflects of markets. our XXXX, the delivered of QX brands at the were buoyed year-over-year comparisons of the this better performance by antibody QX the in COVID-XX provide across first as revenue we trends quarterly revenue, in destocking vaccination first volume as both Europe, in most On underlying well QX was will followed China. driven we This the U.S., looking of worldwide stocking the year. excludes business. half by QX and complicates the strong encouraged of geographies, increasing COVID-XX

Turning entirely in compared grew by to currency. specifically QX, XX% QX XX to or revenue of percentage growth was performance XXXX, points. driven volume XX% This constant

$XXX sequential the on healthcare growth and products recovery continue signaling basis. quarter. see this to our continue the related drive line this business the in growth Cialis We When previously which As in quarter, grew saw destocking million for COVID-XX QX the QX our our stocking XXXX. highlighted, to business. systems same in reversal top core business X% the that up core revenue of from QX the related represent XXXX of strength QX sale quarter, XX% core and XXXX, XX% revenue, were business growth antibody COVID-XX occurred product the China, and pandemic the from we of underlying in pleased of pandemic excluding in our Key

XX.X% impact gross non-GAAP on the sold. QX, of Our inventories XX.X% exchange margin or international was in excluding foreign

increased Excluding to XX impact, compared last approximately gross the year. points by our basis FX margin

expansion expand this nearly XXX half year. Our We to year-over-year was in improvement margin XX.X%, non-GAAP second representing operating an pleased we of see the and margin of operating were basis continued points. expect

Ingelheim end for submit submissions plan tirzepatide planned tirzepatide with type April, for under positive milestones of Boehringer Breakthrough achieved pipeline first in trial multiple cancer, HFrEF On for and the Phase announcing with Phase HFpEF HERX+ Jardiance for only front, accelerated to designation the patient Jardiance and obtaining HFpEF, SURPASS-X pathway; in lymphoma, results diabetes for our X this by Europe; successful the earnings partnership X since to and and in early cancer. and pirtobrutinib Therapy mantle-cell the results SURPASS HR+ in for Verzenio in in XXXX; trial and approval global X tirzepatide population; the now, the FDA the receiving in EMPEROR-Preserved positive announcing Phase donanemab trial approval of announcing X call for we trial our including from prostate for results in initiating program breast

the and Protomer We the also with development Technologies. We business our technology Protomer Lilly bring pipeline pipeline. augment are our to of excited this and announced to team deals continue to to diabetes acquisition welcome

to the treatment with As improve we next the become believe maybe life one, for of people generation sensing quality insulin living for glucose is diabetes.

returned Lastly, the program. the in billion stock shareholders $X authorized addition to to $XXX the on the repurchase remaining up repurchase share of quarter and $X.X approximately repurchases and authorization under in to million dividend via we our billion financials, share XXXX in

including in slides company's field, a solar comprehensive Further, we new largest May a X, the own and part social website progress. a recently at environmental, a in as a our provide serve as goals Kinsale, is new updated highlighted to increased to as QX well on of ESG strategy which of our resource launch our Moving since and of Ireland. operations goal carbon-neutral and which to our now X ESG webcast, sustainability you'll transparency as regarding key see to inaugurated list the governance the our manufacturing call, in efforts, become and plant our earnings events

around income work announced therapies to by pandemic, COVID-XX. as impacted low at we’re of lower of income combat the no world, middle the cost and also are proud and to donations COVID-XX countries, we heavily having We the impact

and the provide call our QX guidance to to update review on financial results Anat XXXX. for our to over an turn I'll Now,

financial QX focus XX% Thanks, the Dave. on compared Dave strong performance business. X items for representing this mentioned in year-to-date. increased and summarize excluding second non-GAAP quarter X or Slides I'll quarter our comments core XX% to the XXXX momentum performance. earlier, Revenue and my

in compared markets, XX% strong Verzenio X% the with accurate QX and in with reflection the Jardiance. of COVID-XX the reps the seen stocking, revenue and We're back growth excluding points many our half in our currency, the sales of U.S. core destocking and related performance, the revenue business, key nearly Verzenio brands COVID-XX performance share pleased for Sequential XXXX, suggests major sequential rates expectation core June, growth majority represent or to between our the strength business. Taltz, of better prior in antibody X the more particularly revenue QX like revenue QX underlying the across Trulicity, field, year. was exiting grew and growth vaccination increase QX from total constant to now and is line a quarter-over-quarter Given prescription from in of percentage volume first being in quarter. for recovery the in the in pandemic our growth

declined The rates to in effect Gross in represented a While driven other decrease increased products percent Jardiance products key These Taltz sold. growth was margin in international of accelerated. foreign business XX QX. basis along points market of Trulicity, the leading percent margin share exchange gross their as inventories in and growth core this revenue primarily with class on XX.X% of revenue same the while XX% by period, unfavorable quarter.

in of investment quarter, period administrative in meaningful expenses percent selling $XX the customer-facing compared direct-to-consumer approximately to XXX a investment, of Total compared million R&D grew lebrikizumab. driven XXXX. for QX XX% this as operating million last operating XX% Excluding exciting to XXXX driven second and million settlements was base XX% the the a this continued we points as increased by first of reduction Alimta. in a year. QX basis to This and of by invested operating the margin increased as income pipeline XX% increased and our European expenses expense income compared year. gross and QX, Other to also in grew QX quarter this revenue of XXXX, pirtobrutinib, expenses the $XX tirzepatide, Operating XX% FX driven growth and quarter, system by and to impact, of $X was and health therapy’s from quarter, of $XXX included XX R&D patent in expect to in half same care points of quarter. income of Marketing, we compared this increase expense XXXX, marketing for the XXXX opportunities, XX% bringing as year-to-date. closed. growth Net COVID-XX approximately increase percent growth, In investment compared was margin XX.X% COVID expense for income prior expense outpacing was revenue R&D R&D of year. expenses COVID-XX income including million the late-stage an expansion half total QX donanemab revenue

XX% discrete effective net earnings are growth year-to-date per and volume the by both tax QX, of effective currency. revenue line, on growth quarter respectively, XX% increase discreet X, income the increased and we points major tax rate basis last tax periods the second encouraged for Slide reduced rate with by quarter or our were At across reflected net XX% compared And share quantify price, The On seen in of and in geographies. rate XX%, constant lower an was XXX bottom of the and effect the world. we in across Our benefit XXXX. XX.X%, the most of with net same benefit, the tax year.

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over share returned to billion addition, and dividend shareholders In we in $X.X repurchase.

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revenue XXXX goals for to business in EPS our are while achieve ability We confident core delivering mid-teens our growth. the

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over to call Dave Now I'll remarks. back turn closing the some for

I that. Dan. Thanks a appreciate lot,

year-over-year the driven sum by progress was of strength dividends Alzheimer's business year in in QX year pleased progress we've during Before We expansion. to of quarter donanemab volume-driven sequential reflecting as tirzepatide new $XXX seen Q&A, an approval this and positive core made to million across up first strong momentum growth results growth in this in as brands and made developing in we top major announced QX. We've to quarter for repurchases, million as the we our geographies. pipeline quarter. returned well as significant in $XXX and half as nearly and confidence for in We're increased This line me submit see strength HFrEF, Jardiance is medicines, and most share type our in go this margin in to HFpEF. key the this well our plans X as let positive later another completed disease business. Dan ongoing outlined, We in shareholders through diabetes the

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and issue more this the meeting. in on to details contact in weeks be coming will team IR Our invitations provide logistical

it turn over to moderate to me our Q&A session. let Kevin Now

you provide as many and Thanks, as from limit session, can two for to Dave. we so We'd Q&A the the caller? for to we're that ask ready please the instructions take Lois, possible, like questions questions first caller. then your you callers per

is question the Flynn line Terence first of our And Instructions]. [Operator from Sachs. from Goldman

like And consistent then ongoing they've color study? on how comments can the if to see plans the more if on regarding from off wondering actually But could just expectations. It TRAILBLAZER-X with the you signed data was they FDA fully BLA? to I file much want your your Dan, provide on Maybe, with additional elaborate would safety sounds your at you discussions any they're donanemab. all your

Dan? Terence. Thanks,

that of even June, we evaluation donanemab safety Yes. on have of FDA Thanks data announced Breakthrough on than includes, I then, the more Sure, confidence I'm and Terence. a got package have then, by our the current a our to enough our we adequate we understanding support year, that and the was and designation would for end safety. that based things That to of the and the the benefit/risk BLA when progressed the of say of full file this situation. support expectations drug. question that an now submission to course, this Therapy In confident of have we end by I was should complete year. Since

the dosing, completion enrollment of of duration limited as given think near given TRAILBLAZER-X. I helps as now that in well

safety it's So completed Phase use package. the that early safety X our data support X X and intent well from as look Phase from data the study Phase to ongoing to studies combined an at as then

safety consistent as don't of we show. I data to assessment data study, support prior always Now it's that, then course, a risk. should know what is to would with and we've said. track think going any If be benefit/risk to collected there's We on with next put confident positive that we the also year, ongoing safety us that launch study,

from Gal the question And next Ronny is Bernstein. from

Two, the stay I'll first one, donanemab. with

-- do you a the there with by your entire Can have to seems And does differ amyloid forward? Basaglar have to expect second, it a donanemab discuss of little other the a to donanemab. Can that of price β? how you you see you you're seeing approval of And about going we drop suggested there biomarkers use good bit essentially, from Any what some the bit as a how this use that little quarter. you are we the of should interchangeable of you be expecting talk have What go through bit comments early And will impact the And use markets commercial do the You what in how of think the first about there? proved developing here? in a when? forward, kind passage that chance biosimilars? are franchise? patient

the on We'll questions and on the Mike Dan for questions donanemab, then Basaglar. go Mason Ronny. to for Thanks,

for biomarkers their on and Yes. the question Ronny, commercial Thanks, use.

this been area progress Lilly. an has by great of investment great and course, Of

We continue a emphasis here. of lot to put

biomarkers. it follow a are their tools, disease not research-only treated think application. ability disease been be had you for with available, clinical those have as of select I that treatment the future. in objectively, for clinically should kinds who We Alzheimer's now we're and to wouldn't for response patients treatment seeing had Alzheimer's progress the to That that in the don't being the see in patients --

course, with with of the the of Tauvid in use quickly the now, be PET Those launch Tauvid, of that of somewhat status but Amyvid. tau approved and future. right the limited for could both the we is imaging now is scaled agents, donanemab both, are imaging right amyloid availability the with tools in FDA particularly So PET the PET

agent, one patients be phospho-tauXXX to is assay. third probably is the The the will that accessible which most the

their even impressed continue more to today, shown we're track to assay, on ability identify its work that patients, with performance, we and as and as progression. more its Just I've

in to in lower be diagnostics term. We'll good could bar this hard there's an there. So is answer often diagnostics. for for in near the potential available. vivo make think vitro I And that The work and patients

You happens flow that and donanemab approved once launched the that around the these are patient time all asked and before. presumably, available not but about things

that positive, a I patients practice probably eligibility could assess test they evaluation. if or blood-based that support fit cognitive that phospho-tauXXX. to either triage think that's data with the exams for and by to sense to it with medical could would a screening patient's move depending on physician a simple on If then like early some starts make be of would sort to PET treatment basis scans if for further Alzheimer's,

Dan. Thanks,

the Mike for around performance Now to questions QX Basaglar Semglee and interchangeability.

by Yes. Thanks has for the pressure the in seeing Basaglar. 'XX and pressure driven in primarily segment Medicaid second Basaglar. on of volume quarter for you're that the performance been The question pricing

me you then drug works. states: Let little preferred X give X those have signal of a Medicaid managed list different that different have others really of of unified kind across segment types preferred unique one on fee-for-service; how There's Lantus. like economics Medicaid. and transition Medicaid that the favor for state color one and having states drug Basaglar seen to list decide a with the unified list to long-standing drug different managed the across drug What list, for brands a the to is we've and fee-for-service when from preferred preferred X tends bit

And see estate managed you'll see in transition to have a Medicaid, so point, the back for at one -- Lantus. if we that you

space, we put that's preserve some volume So that. for has seen pressure from that have Semglee on QX Medicaid to us performance. rebates -- managed in you've the in there more pricing what our the required Also order to seen driving

baked of Basaglar turning for to Now to remaining let the into turn that of me XXXX. first all, the know well, kind fully for trends -- guidance Semglee, of part before are our

Semglee. to turn Now me let

Semglee gained Basaglar. First Lantus, just not of with that all, with interchangeability understand has

anticipate So immediate on any Basaglar. we don't impact

the has Medicare the of on date, they've about TRx market look A, from performance treatment starts. X% to majority vast Medicaid of and Semglee you the come If which captured segment. And X% and Part hospitals, share is new about at of that

packs it's to pack And have $XX we that at is of costs average requires of any monthly $XX which regardless at prescription experience, raising diabetes vials has in for Lilly insurance Value less out-of-pocket vial with of price the of lower insulin, affordable multiple status, anyone, with which $XX.XX our the insulin for interchangeability, Semglee, deductibles. pens. Lilly health you point a If the X includes patients monthly prescription or $XXX is and actions why of or for Program face Value helped out-of-pocket per insurance help The also to for through or eligible their Program. pen more buy move Insulin support look insulin -- about Insulin currently the really to

living lower with costs. diabetes options for access to their people to out-of-pocket it's So the question. many that Thanks has great

And from Tim Wolfe the Anderson next is Research. from question

A couple of questions.

to the across some Just dose But docs that. enough you drug not would I maybe argue you're that can does the your blood stick to more drug infusion. offer pursue obvious quite antibodies meaningful believe shown seem Roche general has to so And because being a able plaque, they thoughts falls worried subcu you on Part barrier. home. originally framework, get achieve an would us B did brain inclined wouldn't with be that Medicare it dosing with subcu a high that a differentiation? outside to At at level, benefits of

So as And meaningful separate endpoint? why study require right stream revenue something Lilly plaque And quick a own P-tauXXX Lilly? a question, become at pursue expect can for last looking subcu? wouldn't we this might would Phase its formal reduction like primary a then also X a in

We'll Thanks, questions. Tim. go all to for those Dan

good for mentioned. therapies. into account the dosing factors taken Okay. addition on it's anti-amyloid questions line here question a Thanks. you of in subcu ones No, to Probably have X that we and

most and clearance here. that and support key far I we so notion is efficacy data for suggest think important that the deep the patients. And is First all have rapid of and

not can going be so possible to important patients to you clear. enough And That's you're subcu if to sure so that drug. always going every it's with in you make dosing, to drug get get go quickly to do

dosing think duration with of the I therapy. is consideration the subcu second

rest of your duration it's between a X the between subcu, months, limited if month not difference big difference. So and Whereas a bigger that a that's is the and if IV if for it's maybe life, a therapy, of IV subcu. difference once it's for

Finally, for I get it, the think respect you option some to prefer limited comments, for important a with previous to do notwithstanding subcu, assuming duration plans our may patients, of therapy, can kind offer patients an the even it's same efficacy.

the given donanemab, with think need to unlikely we pursuing I possible, be formulation we're we that's the and and not doses have. it

we sort able here quite it is which expectation development However, the is in be similarities donanemab future subcutaneous drug plaque enemy. second-generation call seek think of around comparable that with likely accelerated that of as a IV subcutaneous to is lowering an to although dosing. of version given would that My focus between presentation. in drugs, our the it And does dosing we pathway with be NXpGX, new I around is we so, that viable a subcutaneous approval antibody have that a a as should show amyloid If NXpGX. donanemab, for the

for phospho-tau through be think and of and conceivable plans But I the Lilly, our treatment focus stream. assay for significant companies, some really Lilly, It's though, was Your to revenue of second patients. a and for significant question is around that. removing haven't certainly whether for around we may thought our it barriers that's sort commercial on all

about our that patients we and position be most get marketplace, And so therapeutics focus think on sure we appropriately. can possible as diagnostics how will in the really making treated

for this Dan with end. Lilly I side class a thanks, to They're drugs. There get in just always it are priority of require for short-duration physicians Dan, to by said, comment are a important we on which make watched therapy B. imaging and our a their and initially and back think real Tim, be at donanemab patients value access -- the Part the effects, payment how There to clearly like analysis going for to environment, benefits be on to anyway. maybe closely going in And the treatment, then is easier solve

for be therapeutic treat time, classes, available so seen by managed an our self-injection at pharmacy, convenient injection a But it's with perhaps will we've or more disease. primary through to as And in rise care, antibodies form preferred. using a comfort intensively particular, in in would Alzheimer's, level as caregiver, local other

the channels, committed with treatment and the intensive -- nature So days, in the day. pursuing we're to our solving we're both favor of plans patient up line infusion. those will specialist at But end for probably the convenience early nature although in of and the both,

The from Chris Schott next JPMorgan. from question is

Just one one and donanemab on then on Verzenio.

the to to just very is to Phase think My in in we important, event, terms the donanemab I expanding on broad question just anticipate regression than you we're I was here. even I antibodies do Aβ I'm commercial additional being Just the on the saw guess market definitive I a definitive guess or think, for about the thinking my least cognitive at reduction how of these bigger going point opportunity? or less just significantly update. role just were -- products? this Verzenio on usage, available? of X? still donanemab just the trying do to readouts going plaque you cognition cognition see you the is see whole at question is, data the you move say, prior X-parter what maybe So are opportunity say, Or in cognition data do see market second you to let's

think to maybe Just when you'll adjuvant? hard we it population? incremental identify opportunity XX% do think that initial other the of how about data the for higher-risk these as is you OS And have in commercial the patients

Dan We'll then questions on to go the Anne donanemab, Chris. Thanks, and Verzenio. for for

Yes.

So your it break -- is two question in I'll maybe parts.

is drugs. longer the like confirmatory important benefit in term [lung] a is amyloid term, the data to the cognitive how surprise. And happens part what in plaque if additional studies give then near first The negative for have

link to and will different, exciting. that's short clarify be will that for primary There we II published be the some exciting, the being we England as efficacy I'd willing that's only the you still in New going data who that make I'm confirmatory lowering in helpful study to most. that's unique before showing today, have as believe Journal, even of donanemab, between say, amyloid those I and to good that donanemab that's cognitive surrogate is II confirmatory efficacy in benefits donanemab. think the data do, the and that a that successful, an Fine, And to donanemab, term, don't physicians, think I I have who are data going a data. are drug aspect cognitive for until want endpoint for the plaque the come just physicians So Phase drug have well. trial use clinical studies. its Phase then The if And compelling sure, in be position. that data, the the to thing But to unique amyloid lowers plaque want you're positive exciting we I

be and sponsors, we say a negative, for way was clearly that of that retreat wrong acknowledge multiple drugs a multiple would to thinking. everyone think thing I all bad surely and have are if would this

scenario is that unlikely. think I extremely

I is think mixed a scenario probably the likely picture. most

be Some better than drugs others. will

trials others will might reach not. Some significance,

the heard have our in me trial, You've but confidence the to speak we about see data.

I that strengthen notion would is reinforce the amyloid be amyloid idea. think in -- scenario, important a is will good that enough reducing that and that good an to surrogate

on Verzenio? Dan. Thanks, Anne,

as key as of median shared, with two out the for follow-up. shared strengthen we're as And Dan IDFS incredibly monarchE of thanks with data we continued have have pleased question. what he years Chris, Verzenio now to are And endpoints, seeing further and the and follow-up. Yes. we such

broader very OS remain as confident the he very that, with we will Verzenio shared, in so favoring trend pleased And there population. be and an

label in to our So we would future. these patients the to the FDA include with work expand

So is obviously, event this and event the so the of determined rate. be driven timing will by this

analysis So further of of in analysis. 'XX, analysis final is that the this timing planned really and the next our will help second us half inform

favoring trend We overall we're events analysis. low But the that the population see data what still seeing, confident needed commented, and still the and immature. to high than OS both in we in this do remain is again, you broader have OS final as So Verzenio with performance to survival of less XX% strong the in KiXX, to replicate.

is to already easily really is an monarchE assay, simple methodology highly available is a concept It in labs. IHC really As so that far factor good these as assay. used that accepted really broadly physicians. cancer. KiXX, here accurate in we as breast very assay And familiar prognostic reproducible. be news And straightforward it's on this a And to performed and proven the the and and are the through pathology is

move oncologists highest this quickly And with I will that the is really, in to our this to uptake in help So in adopt belief accelerate setting. will risk, think, patients practice. this clarity

setting. to look launching this we forward So in

caller Evercore. ahead. next Raffat go from Umer Please The is

so for thanks question. about Dan, Surprisingly, today. three much to taking I want Alzheimer's my I Hi, talk also have subparts.

you Phase dosing the First, on amyloid new causality? Journal benefit you review? expect dosing. data level of by association Because you trying XX once duration do finally, no regulatory recall I suggesting understand there's nonlinear Biogen's much. versus And reconcile clinical slowing the X, relationship plaque Conrado data decrease subsequently? plaque also And are you your rate XX% clinical are saying to showed and suggested similar. a of of I'm in there clearance have of to expecting the Are England slide might the was Secondly, paper and ongoing to very I'm Or filing on then continued the a you you on Phase New plaque a and Biogen cleared, the patient between on finite expectation trying between months, think relationship? from model, what II patients saying mentioned onset you opinion model, Thank just part III your is during of a the or as your use interim plaque at progression. there's

Thanks, Umer. Dan?

Umer. Okay. Three Thanks. questions, great

that support data that in at you with don't question, the commented safety I we'll asked need data. see plan submission use we'd submission to to the So cut efficacy do submission. any data, take support right that first support We interim of looks or to we way a if that the

adequate efficacy submission approval have lowering, the which be basis plaque We and would supporting data the accelerated of under approval.

question that some how found is long data also of take that plaque once to is is it AAIC. off slow, second was very come what presented it we therapy, But really, I back? there have highlight We morning. plaque. negligible, this didn't Your does at regrowth that clears, on

like fully of average you XX or And take in The something sort patients it haven't is we of disease. remember, years XX. it halted I this think that extrapolate XX trial regrow plaque. if progression or age might amyloid out, to of

But be feel ability thinking many on for redosing like to years have them necessary So that many, will follow we'll confirm near-term that. and keep clear. doesn't a patients the to

so the initial think I Finally, prove that we correlation. correlation. of is reporting you've course, see we a causation And didn't a analysis, we correlation that are that? can't correctly is now our which situation, is do just summarized and it Why in correlation see a

quite we do it see depends we plaque you remove plaque lot So now? that was that's why interesting. you start of a have And learned the I what with. amount how to think much on

you you only so plaque, there's only of can centiloids remove. XX much So have if

based plaque lot of on, more. centiloids remove XXX have you you a If can

to who kinds in duration, age, plaque pretty disease, turns have and progressors can perhaps more more who might severe lower be you you at the baseline, The more compound correlations. but people than have older lower people might they remove of -- So cognitive are they that important have performance, plaque out less. worst the a longer these still be remove

a covariance. So, look important our change on baseline straight maybe backwards change without of thinking to all between those correlation was thinking, and for a adjusting field I for think the little this bit initially, and

of from line ahead. the is question next our Please And Andrew Baum. go

of couple A questions please.

progression disease a analysis standard TRAILBLAZER-ALZ support much accelerate regulatory but the review, you're to to for accelerated back using so the Just for readout not model. used interim Bayesian as going to to full

to your And approval such perhaps to in have capacity in possibility Alzheimer's and those well patients? assay, assuming cognition of getting linked accelerators. second, follow-up to there on we you that attain regulatory Or early that comment weeks? outlook full could you're the clearance donanemab that of regulatory to you these for have Given unblinding by the patients out then that's that, efficacy as going a the go as the for manufacturing do P-tau driven XX a on Thank is you. the assume who rapid is

Thanks, go you questions. for Andrew. those to Dan, we'll

Yes.

interim you've TRAILBLAZER-X. Andrew, a So lowering, on review whether even rather, of keen an an in forward the kind earlier accelerated important accelerated a be for we'd here, plaque asked the pulling potential that still by on data an question of for approval, face to follow-up one, get bit

that haven't ruled out. We

don't moment We at in have time. plans this also

just to are -- priority, we less a III Phase where trial pretty be the to data maintaining see field gives pristine faster. have then the patients think where we and medicine, But approval get I the the probably particularly if it urgent need to really, would accelerated is. access for a becomes that path to high

of have capacity. to of launch been to manufacturing With diagnostic, that's to And fast good or under and we that's can working and lab-developed that. sure even respect I there follow hard support including location, enter the a to centralized commercialization we are thinking. that's done of in a which the someday PGX our be in make diagnostic, forward for different P-tau feel an So vitro current for consider. hopefully paths donanemab about where test, CLIA. pretty LDT, that we example, are a We've growth path options one and a

Louise Cantor. from Please next from question comes the And Chen go ahead.

taking for question. my thanks Hi,

determination So antibodies disease? pricing And second treat had outcome coverage would national of about how the donanemab question you. it first Alzheimer's you if Thank question do about I potential for how for is, you is is, approved? you to think then monoclonal a think

Thanks, Dan? Louise.

focused Thanks. FDA was sort questions on I the Okay. population. indication when was important. first of course, came, that it subsequently, the the working the that's of -- it focused quite national I decision, donanemab. one Two then When and sponsor widely first the patient commercially broad approval said on think with the -- coverage determination mean an

could I still further be that think of the requiring one form could In here. may focusing to take. patients experts pathology. in amyloid or plaques have be even of at the CMS direction pathology opportunity tau evidence there it case, for And that's Alzheimer's

It of As nine the so take play probably before, we that I matches some right think And it's some to our part that will I too to and goals out I surely simply pricing, think our what months time early way. will thinking said in and be over right. of and say data or that. for then and on next the share on those comment is discussions I think

We time have yet. some

Please The go Bank of from America. call Geoff Meacham next is ahead.

therapy during on duration of number or then estimate you. data donanemab, on today, Dan, couple the as is is TRAILBLAZER a a patients safety, provided that what has the you're filing so then benefit in popular could FDA real there for have And I from for the quick On hurdle of for matures, of more review? your tirzepatide. either be? the terms what ultimately And just

this geographies the you factor look prepare? guys Just as filing. the and point, at gating complete you wanted the to At what's you different as know

Mike the questions, go Jeff, Mason Thanks, for to Dan then we'll and tirzepatide. donanemab on

Yes.

to for benefit and exposures a assess So with respect broad risk it's donanemab for of adequate safety really, having hurdle the or duration a of to to given drug, drug. the fully exposures any population in be able

the data treat the that of that of also number not of therapy, the particulars the you you to a drug, course, population, depends Now safety that's the efficacy on duration the around course, hope collect. that of the and particulars but data

a drawn. be line particular comfortably said, discussions, I each But if on as sand was end be there So this Based easy, I the as and think tailored analysis could I and needs for it and our in it think, there the year. said, thinking current of at be I drug. and for FDA sponsors would the nice to be that we'll

you're data I of We decline duration on which the still duration think, benefit question appears think the But the plaque that benefit. mature. between are sustained. was second declining. as I duration average it cognitive was the TRAILBLAZER getting lowering, Geoff, about I be of commented Your about slowing the a on -- at patients of of see to

data, later that. showed that You on could And of even some not additional perception to the time. we're at And over But expect that, real together initial over were there the I the been comfortable lines cuts statistical I to on would as a the have that coming the data the diverging methods. at would therefore, have benefit diverge as ask, think, or are that data, lines here pretty we have too we look time of points, might raw apart? going I think the that continue slowing lines time. I soon

Thanks, Dan. Mike, on tirzepatide?

Thanks for Yes. question. the

Phase type and Our III SURPASS for program diabetes X completed. done is

here factor the of plan regulators, global regulators. we gating only the So which end is to quickly summarize submit how data the the can and we to major do the year by to

Gould from caller Barclays. next the And is Carter go Please ahead.

on just the past it Trulicity in if is just the guess has the it. the stab appropriateness comment it's obviously, And And and pricing today tripped but Dave of dynamics. in you already benchmarks XQ try sort space think the take the then question. around the I'll about in could in as elephant pricing Alzheimer's, appreciate early, room. of I Maybe another team to at I maybe

you. specifically? just there think on hoping, could you XQ more just offer bit So headwinds a pricing if Thank into you as clarity little about

Carter. Thanks,

for So Mike we'll dynamics. the on for pricing donanemab, on to pricing Trulicity question Dave go then and

limitations would at we what Yes. probably I of There's, curiosity. lot question, the the say of get appreciate as totally we this understand, you and stage.

really reasons the in the can is we its ultimate of disease input demonstrate and for the -- that space we have pricing. or for -- endpoint reduction One customers the And the progression study the have are to hit is only key. value key we at Lilly disease pre-specified limitation fortunately, a for label and reduction, those

As we data. that cut demonstrated at AAIC, we continue to

question process, brains the we could with ways the elucidate how this completed earlier about well. in what in donanemab Alzheimer's perhaps biomarker study we NCD differentiate continue the one an not. that in are as of have product was there them patients can think those of but others might that's to I does And inputs and exquisite as of profiles

applying can a low that access the outside. as this been And partnerships to well easily make appropriate as cost Finally, in value-based out-of-pocket thinking sure or U.S. Lilly really concepts the well we're as that at to in has problem leader patients medicines. and

approval, it just but make could U.S. could of it the in goal millions that one. people to the qualify sure day who to all for on Our get isn't an access

you wouldn't all inputs the throwing are color process it. about number scenes. until here, be that that which So some we think an Hopefully, those out behind approval. gives we get into how a without appropriate and That's

And then pricing on Mike Dave. dynamics, Thanks, for pricing Trulicity to trends.

really and so take offset At utilization, would the for the we're increases, nothing rates to of in and to low by year, question, of for pricing. lower report the beginning second new impact market, list we nothing single-digit that you at price the price year, Trulicity. on XXXB Thanks look see update Yes. gave decline what guidance increased Trulicity modest when the experiencing, really and mix for a at point That's the that year. new this we

Yes.

third And me and on through Let comment does year, conversations we've it more tend the there had add to just this. pricing on does -- movement just some know I general numerous be more and tend care second the through the gap the do We year. year. as quarter in impact flow from patient of the see pronounced coverage health throughout the to volatility system,

what And pricing And year we that see dynamic, at the now, for we terms full throughout of it's dynamic that. erosion. into -- every full built overall as in really every and year. estimate consistent color discussed year year, previously more terms obviously, have of said. the guidance as for pricing right we So provide those our look in insight, you we with Mike But we'll dynamics as U.S. assumptions

the expect You year, the saw which you X% year. for is the should first of for full half what

ahead. Fernandez go from question Seamus The from next is Please Guggenheim.

Great.

published regard update to a think I hazard And at the to ratio. cancer it the of with XX% So prostate on forward hazard kind in focus power. X.XX, AACR, wanted was relates abstract and details in abemaciclib provided, were threshold as for the an of some that really it cites the sort moving in ratio to provided of of

X.X with into advancing continue of I stage CYCLONE to, of So the X. think, a P-value next

just force to we that, a consistent that like into is information to if a piece magnitude patient of the incremental just would as that a limit wanted as could so seem then robust going driving wanted say, Lilly are, that moving for and head to of this clarify And follow-up. have of as any biomarker there of that to the sense the get forward, So if Verzenio other that. the And would or population. the RB, retinoblastoma-related requirements believes then size opportunity a enrollment represent requirements just let's for forward. And for information

the than if being terms the of class. product products for if independently any the have a and In determination, product, its would the Lilly's of pricing initially to as treated own reason independently part rather NCD Lilly price of has argued as NCD impact just clarify priced the ability of why wanted on that's the part to

Verzenio, for back going We're to and will round then we'll to the that NCD Anne it Dan first start to out, to question. follow toss then Seamus. Thanks, go to and Dan on

Yes.

about we was asking, You're very was. a the to get want you're I But Phase the it very details to expand a study correct study. that to very Seamus, the that into III threshold. our from II precise study smartly think criteria Phase don't on what robust

to So starts Phase excited We Phase we're see failures. don't III that We seriously want take III very at happen. Lilly.

have where we III that studies like to to move seeing set from area any this in therapeutic without we So Phase have one, really forward ever aggressive when move we III. Phase Phase data the II to match to bars data,

that's for more So detail. Anne you here. did can what expect we

and of see Anne, more the prostate? also in the there for opportunity detail we magnitude Dan. Thanks,

the I as just threshold. And outcome Dan of were very and I differentiates aggressive with example that and we the met said, threshold recommendation another incredibly and continues be pleased to think Verzenio we're on it this a set by this Yes. mean, DMC, it competition. how from impressed we adaptive the design, that

the analysis patients. in is of III Phase already enrolling the the anticipate We open. So XXXX. It's results

not X it's earlier in settings. so prostate metastatic cancer hormonal on really trial question market targets have castrate-resistant patients size, prior so a is yet novel agent, the -- CYCLONE that On who received

be shows So could addressable to XX% that CRPC. our market initial the of research the in XX% of metastatic range

in how setting. really that depending it's So earlier bit evolves on the use market a with NHAs the of

CYCLONE of as So for in on XX,XXX length duration. also And need long being space that, X,XXX anticipated unmet estimate match the inclusion would in we between and example, patient a based U.S., currently there's this treatment patients for exciting X. high that long as is criteria that a large population, in a

two So or longer. be a to of up this could years treatment duration

it why or study. other So is excited no that's we're delivers about opportunity, There particularly there. this what requirements biomarker the in RB is

Thanks, Anne. Dan, on NCD?

we and on primary evaluated Is -- merits. something be Last did is be even question its different. patient here we allusion my I that NCD which, a on pricing and on that deliver, why an was class, outcomes that? could that same to the own drug or No, should drug could think the each within focus the say like

same I above want important can and today not. to quickly and different the remove anticipate I be scenarios how most of to that amyloid is and theory scenario, others you may easily some even conceivable. is what for coverage is presented case, you patients be that amount a imagine benefits for predicting those and here. benefits Our you but that all threshold having data outcomes. support theory, Not of may That's that's If for for the prepared class with drugs, likely do different the the we

Please question ahead. next go is Mizuho Divan Securities. from The Vamil from

the Thanks the on pipeline. for all updates

maybe sort covered topics couple separate of call. have that So more the on a been

what a but set a product, maybe Can for lebrikizumab, gets on underappreciated formidable dosing that a III potentially bit. maybe little you one you dupi's clearly data see? one obviously, that have I know So hoping and with some got to We Phase you're coming up. there. pretty expectations just advantage competitor

I quick tirzepatide, pursue And just at you I'm don't that if I know -- you that. of not, that why hoping HFrEF what HFpEF So that. wouldn't frame can I see. maybe product. sort curious said, you follow-up. you mentioning just I you started, well? the for study think as for you're And just remember just one then Are mentioned you to you looking

question Thanks, tirzepatide. on for Vamil. to and the lebrikizumab, Mike for We'll go Ilya then

Thank Great. our you induction -- excited the across half the related question see to for lebrikizumab. lebrikizumab We're the of the data number to for for on of second phase to a year trials.

positive to profile. saw we're in replicating what the believe we where strong see itch, hoping a efficacy is see some to and skin signals we have of so Phase and in have And II, expect good safety we very

significant important And in dermatitis, And growing we anticipate lebrikizumab only will in unmet lebrikizumab for a dermatology and our have being asset a profile DUPIXENT as versus overall atopic a think not that presence competitive our so we franchise. strength growing very us an but need. see and immunology we and about

Mike? Thanks, Ilya.

we're Okay. the Yes, currently all this point. for planning on that's we and at for only study question. a HFpEF tirzepatide, have Thanks announced announcing

the I you in in HFpEF, think we're tirzepatide a of is the opportunity patients have that obesity HFpEF. confident large at within that look this patient are there's and a phenotype When also population. [steep] very obese segment

about that successful in So I confidence our HFpEF. good results studies us, -- our think I II that we've Phase we be seen think, we'll feel in give the

efforts our And so are now, focused on right HFpEF.

The Please ahead. Steve next from Scala Cowen. go is caller

questions. Two

data? QX see, particularly as And competitor said, not events, differentiation your monarchE, SERD, Lilly on differentiation me-too provide basis? SERD. see numbers ASCO the Lilly so, it with flow has a you update Lilly would if an XX for like-for-like then potential a the in said secondly, and what data it And on earnings did control. there call, on been did on pursue on evolves? news previously in First, XX had Can abemaciclib, oral XX

wondering I'm So about what yours. is different

We'll question Jake and question differentiation. Anne the the Steve. for then SERD on to first Thanks, Verzenio, on go oral for

presenting a we're Well, going be meeting shared, this from to this data thanks, later analysis Steve. at year. recent Dan medical And as

So as obviously, see than can we more to latest to the and pleased we to But tell, in of years follow-up. won't then, this very able details the continue strengthen two you further analysis be are due embargo. share with to data

As overall previously, we immature. the stated remains data survival

the we events less share needed, prespecified XX% than I OS have point, half the of for can events what this of analysis. so than at the less is needed So

the were that at meeting trend. So data later risk really that even look more and question But Again, we the had sharing pleased, with patients a for remains highest favorable thanks to immature. the to forward see with already immaturity, this on.

Jake? Ann. Thanks,

pharmacology expected performing We're take that everything doing on it Sure, clinically. from drug It's SERD. pleased the to happy question is the we safety with how to do a efficacy perspective. and

what the presented to to that and trial with drug not that a data SERDs data I in agents been own on breast unique we par at But ASCO statement. And the is it placed the development really having competitors emerging that development about bit ASCO, more of program, a of medicines. as data light we from think cancer, leadership all development its peers. best period. vacuum a I our the That think this would our talking a in that in I we've randomized in to about as today, is and position medicine And class we landscape, see in relates which it looking interested our some relates said, me-too role This forward drugs position is stand paradigm. treatment think frankly, this a in will program. stands fit I the subsequent in not I ought some and of where in package continue overall that from think later we me-tooism, that on also shed time year pursuing as these in by I the we're to to put think, particular, long-term cautious Verzenio this to the this on a are with we're first been some for us class of say

go And Please Morgan Harrison Stanley. from comes ahead. that Matthew from

for guess me. I Great. two

model? at explain like So little know this of seeing compound? if more combinations? on just wondering Would you model, you all regulators you're this to parts look first, the a plaque. that one, I'm only SERD, clearance. a with you've just And we're XXX% can seeing assume other And combination what just of follow-up secondly, expect any detail, that it view to Conrado regression, why a maybe on then looks XX% slowing you in I with in XX% do about then two the slowing is plans sort over at cleared XX follow-up just continue when months. CDKX/X or a to second bit

the go questions Jake Thanks, SERD. Matthew. We'll on model, Conrado to then on Dan the for and

and on we're built, for data against don't consortium view clear, CAMD for be. by a patient's that would checking though, there. the have progression this -- encouraged and from progression has applications. was is question what used be predict the while a around said for But we No, regulator's the a the I doing here, earlier, as we're model been various Matthew, What CAMD Thanks, their model. Conrado to we Yes. by

they progress. much predicted versus to of baseline the their have factors, how actually on progressed much not So how they did would knowing all had been drug

in so the essentially you're And what seeing that's graph.

still right, full progression. XX% there's There's even with some a You're only plaque clearance, decrease.

least And play. effect of where at beyond Now big in as but about Alzheimer's anyone we're Alzheimer's therapeutics tau disease. need that's additional come to that's talked clearing just surely, as in this I stage ever into over time, for probably the plaque, has think an disease, going therapeutics

So that's how we think about it.

XXX% I if course, no in yet to proven. slowing quite Perhaps different. think enough, early disease be be that essence, in and the it could could progression Alzheimer's, disease get but have in earlier you it you is

Dan. Thanks,

on SERD? Going to question that for Jake

Yes, a question SERD. on

Of course, combinations, cohorts we ASCO SERD right abemaciclib. combining of that including contemplate same doing I/II our plan for we cohort to rational data trial the abemaciclib. CDKX/X, in of We're now with that context explore at with presented with oral in the which an particular, expansion expansion trial, has Phase the

Thanks, close. and Jake. the exhausted We'll Dave Matthew, the questions, for go to queue. we've thanks for your

all Thanks, of course. call in your participation to questions. in interest the Dan and today's appreciate Kevin. your Company, We Thanks answering those for

and and And U.S., growth breadth across we growth have accelerating see broad momentum with continue a by classes We commercial brands strong of across supported China. portfolio. Europe our robust to core business our and

our industry-leading today, bringing In if great you we have remain a with today, pipeline opportunities, compelling creating have again you day. hope Thanks. questions believe and addressed follow heard addition, and a to value you we dialing focused we patients Please any in. for have new with we not on all up medicines as Relations team and have for stakeholders. Investor Thanks

and ladies for for today. participation And gentlemen, and our you Thank using that does your teleconference service. conclude you. AT&T Thank for conference

now may disconnect. You